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321 records returned

ALBAclone (Alba Bioscience Limited)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - November 19, 2009 Category: Biomedical Science Source Type: organizations

Platelet PGD Test System (2009)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Substantially Equivalent 510(k) submission; cleared 11/10/2009 (Source: What's New at CBER)
Source: What's New at CBER - November 13, 2009 Category: Biomedical Science Source Type: organizations

Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 VirusEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
11/13/2009 (Source: What's New at CBER)
Source: What's New at CBER - November 13, 2009 Category: Biomedical Science Source Type: organizations

Influenza A (H1N1) 2009 Monovalent Vaccine (ID Biomedical Corporation of Quebec)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - November 10, 2009 Category: Biomedical Science Source Type: organizations

Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for TransfusionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - November 6, 2009 Category: Biomedical Science Source Type: organizations

Approval History, Letters, Reviews and Related Documents - BerinertEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - November 6, 2009 Category: Biomedical Science Source Type: organizations

Important Registration and Listing Reminder for Manufacturers of Biological Drug Products Subject to 21 C.F.R. Part 207Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - November 4, 2009 Category: Biomedical Science Source Type: organizations

ProQuadEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Approval Letter and Approved Final Draft Labeling for Merck's Efficacy Supplement for Measles, Mumps, Rubella, and Varicella Vaccine, Live, (ProQuad®), to include concomitant administration with hepatitis A vaccine (VAQTA®) and/or pneumococcal conjugate vaccine (Prevnar®), use of ProQuad® in children 15 months to 12 years of age if a second dose of measles, mumps, rubella, and varicella is needed, additional safety data after a first or second dose of ProQuad®, and to comply with the Physician’s Labeling Rule format, have been issued. (Source: What's New at CBER)
Source: What's New at CBER - November 3, 2009 Category: Biomedical Science Source Type: organizations

Urgent Medical Device Removal: COBAS AmpliPrep/COBAS Amplicor HIV-1 Monitor TestEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Roche Diagnostics has confirmed that there is a problem with the HIV-1 MONITOR Quantitation Standard (QS) copy number encoded on the HIV-1 MONITOR Multi-Reagent (CS3) Cassette, packaged within the COBAS ® AmpliPrep/ COBAS ® AMPLICOR HIV-1 MONITOR Test, US IVD. The QS copy number was incorrectly designated as 107 copies/PCR instead of 97 copies/PCR. Customers are asked to discontinue the use of this lot and to request credit for affected products. (Source: What's New at CBER)
Source: What's New at CBER - October 29, 2009 Category: Biomedical Science Source Type: organizations

Research Technician (Interdisciplinary)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - October 28, 2009 Category: Biomedical Science Source Type: organizations

Use of Influenza A (H1N1) 2009 Monovalent Influenza Vaccine in Pregnant WomenEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - October 27, 2009 Category: Biomedical Science Source Type: organizations

Public Workshop: Emerging Arboviruses: Risk Assessment for Blood, Cell, Tissue and Organ SafetyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Dec. 14-15, 2009; Workshop Information and Registration Form. (Source: What's New at CBER)
Source: What's New at CBER - October 27, 2009 Category: Biomedical Science Source Type: organizations

Common Ingredients in U.S. Licensed VaccinesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Prior to licensure, as part of FDA’s review, FDA takes all the ingredients into account, including the active ingredients as well as other substances. (Source: What's New at CBER)
Source: What's New at CBER - October 23, 2009 Category: Biomedical Science Source Type: organizations

MyCells Autologous Platelet Preparation KitEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Cleared 510 (k) Submission - BK080057 (Source: What's New at CBER)
Source: What's New at CBER - October 19, 2009 Category: Biomedical Science Source Type: organizations

CervarixEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Product Approval (Approval Letter, Package Insert) (Source: What's New at CBER)
Source: What's New at CBER - October 16, 2009 Category: Biomedical Science Source Type: organizations

Influenza A (H1N1) 2009 Monovalent Vaccines Descriptions and IngredientsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - October 13, 2009 Category: Biomedical Science Source Type: organizations

BerinertEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
, C1 Esterase Inhibitor (Human) (Source: What's New at CBER)
Source: What's New at CBER - October 10, 2009 Category: Biomedical Science Source Type: organizations

Postdoctoral Fellowship (Biochemistry of Plasma Proteins)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
A postdoctoral position is available for a highly motivated candidate with a strong background in protein biochemistry. Research area: molecular characterization of plasma glycoproteins using mass spectrometry; heterogeneity of plasma glycoproteins and protein therapeutics; molecular mechanisms of the interactions of C1-Esterase Inhibitor with multiple ligands. (Source: What's New at CBER)
Source: What's New at CBER - October 9, 2009 Category: Biomedical Science Source Type: organizations

Avioq HIV-1 Microelisa SystemEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This device is indicated for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human specimens collected as serum, plasma, dried blood spots, or oral fluid specimens obtained with OraSure®. (Source: What's New at CBER)
Source: What's New at CBER - October 5, 2009 Category: Biomedical Science Source Type: organizations

Donor Information System (DIS) version 4.0Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The intended use of the system is to receive, analyze, and store data during the collection and distribution of Source Plasma that will be used in plasma-derived bio-pharmaceutical products. (Source: What's New at CBER)
Source: What's New at CBER - September 28, 2009 Category: Biomedical Science Source Type: organizations

Order to Cease Manufacturing of HCT/Ps - Vista Cord, LLCEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - September 25, 2009 Category: Biomedical Science Source Type: organizations

FDA Public Health Notification: Vista Cord, LLCEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
9/25/2009 (Source: What's New at CBER)
Source: What's New at CBER - September 25, 2009 Category: Biomedical Science Source Type: organizations

September 17, 2009 Approval Letter - HavrixEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Hepatitis A Vaccine, Inactivated, Havrix (Source: What's New at CBER)
Source: What's New at CBER - September 23, 2009 Category: Biomedical Science Source Type: organizations

September 16, 2009 Approval Letter - TwinrixEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Hepatitis A, Inactivated and Hepatitis B (Recombinant) Vaccine, Twinrix (Source: What's New at CBER)
Source: What's New at CBER - September 23, 2009 Category: Biomedical Science Source Type: organizations

GammaplexEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - September 18, 2009 Category: Biomedical Science Source Type: organizations

ABBOTT PRISM HIV O PlusEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - September 18, 2009 Category: Biomedical Science Source Type: organizations

Approval History, Letters, Reviews, and Related Documents - HiberixEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - September 17, 2009 Category: Biomedical Science Source Type: organizations

Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell ProductsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - September 17, 2009 Category: Biomedical Science Source Type: organizations

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot ReleaseEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - September 15, 2009 Category: Biomedical Science Source Type: organizations

Influenza A (H1N1) 2009 MonovalentEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - September 15, 2009 Category: Biomedical Science Source Type: organizations

2009 Biological Device Application ApprovalsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This list reflects information regarding the supplements as of the approval date. (Source: What's New at CBER)
Source: What's New at CBER - September 8, 2009 Category: Biomedical Science Source Type: organizations

2009 Biological License Application ApprovalsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
This list reflects information regarding the applications as of the approval date. (Source: What's New at CBER)
Source: What's New at CBER - September 8, 2009 Category: Biomedical Science Source Type: organizations

Influenza Virus Vaccine ActionsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
9/17/2009 Novartis Vaccines and Diagnostics, Ltd - Approval of additional manufacturing activities for Influenza Virus Vaccine (Source: What's New at CBER)
Source: What's New at CBER - September 3, 2009 Category: Biomedical Science Source Type: organizations

Blood Establishment Computer Software: Understanding What to Include in a 510(k) Submission; Public WorkshopEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The purpose of the public workshop is to educate industry on the laws and regulations for medical devices that are applicable to Blood Establishment Computer Software (BECS), including requirements for the content of a 510k submission. (Source: What's New at CBER)
Source: What's New at CBER - September 3, 2009 Category: Biomedical Science Source Type: organizations

Guidance for Industry - Recommendations for Management of Donors at Increased Risk for Human Immunodeficiency Virus Type 1 (HIV-1) Group O InfectionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - August 31, 2009 Category: Biomedical Science Source Type: organizations

Gardasil Vaccine SafetyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Based on ongoing assessments of vaccine safety information, FDA and CDC continue to find that Gardasil is a safe and effective vaccine. FDA and CDC continue to monitor the safety of this vaccine, with the public’s health and safety our top priority. (Source: What's New at CBER)
Source: What's New at CBER - August 20, 2009 Category: Biomedical Science Source Type: organizations

HiberixEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
HIBERIX is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. (Source: What's New at CBER)
Source: What's New at CBER - August 19, 2009 Category: Biomedical Science Source Type: organizations

Hiberix - Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
HIBERIX is a vaccine indicated for active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. (Source: What's New at CBER)
Source: What's New at CBER - August 19, 2009 Category: Biomedical Science Source Type: organizations

IxiaroEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Revisions to the military version of the package insert. (Source: What's New at CBER)
Source: What's New at CBER - August 18, 2009 Category: Biomedical Science Source Type: organizations

Access to Investigational DrugsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - August 13, 2009 Category: Biomedical Science Source Type: organizations

COBAS TaqScreen MPX TestEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA Assay (Source: What's New at CBER)
Source: What's New at CBER - August 10, 2009 Category: Biomedical Science Source Type: organizations

Bone Marrow Collection/Transfusion KitEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The Bone Marrow Collection Kit, Ancillary Container, and Bone Marrow Collection Stand are used for the collection and filtration of aspirated bone marrow in preparation for bone marrow transplantation. (Source: What's New at CBER)
Source: What's New at CBER - August 7, 2009 Category: Biomedical Science Source Type: organizations

MenactraEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Source: What's New at CBER)
Source: What's New at CBER - August 6, 2009 Category: Biomedical Science Source Type: organizations

Public Workshop: FDA Regulation and Licensure of Whole Blood and Blood ComponentsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
(Source: What's New at CBER)
Source: What's New at CBER - August 5, 2009 Category: Biomedical Science Source Type: organizations

FDA-NCI Workshop on Therapeutic Cancer VaccinesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
10/27/2009 public workshop to facilitate the development of safe and effective cancer vaccine by optimizing early phase clinical trials based on lessons learned from completed Phase III studies. (Source: What's New at CBER)
Source: What's New at CBER - August 5, 2009 Category: Biomedical Science Source Type: organizations

Influenza Virus Vaccine for the 2009-2010 SeasonEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Vaccine lot release information updated on 7/30/2009. (Source: What's New at CBER)
Source: What's New at CBER - July 30, 2009 Category: Biomedical Science Source Type: organizations

Guidance for Industry: Nucleic Acid Testing (NAT) to Reduce the Possible Risk of Parvovirus B19 Transmission by Plasma-Derived ProductsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Recommendations for performing nucleic acid testing (NAT) for human parvovirus B19 as an in-process test for Source Plasma and recovered plasma used in the further manufacturing of plasma-derived products. (Source: What's New at CBER)
Source: What's New at CBER - July 27, 2009 Category: Biomedical Science Source Type: organizations

Cytomegalovirus Immune Globulin Intravenous, Human (Cytogam) Untitled LetterEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Cytogam (Cytomegalovirus Immune Globulin Intravenous, Human) (Source: What's New at CBER)
Source: What's New at CBER - July 24, 2009 Category: Biomedical Science Source Type: organizations

Immune Globulin Intravenous (Human), 10 Percent Caprylate/Chromatography Purified (Gamunex) Untitled LetterEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
An exhibit panel misbrands Gamunex under section 502(a) of the Federal Food, Drug, and Cosmetic Act because it minimizes risk information and contains misleading safety claims (Source: What's New at CBER)
Source: What's New at CBER - July 24, 2009 Category: Biomedical Science Source Type: organizations

InVitro Diagnostics Untitled LetterEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
10 minute HIV test kit promoted on website is not approved for sale in the United States and has not received an investigational device exemption from premarket approval. (Source: What's New at CBER)
Source: What's New at CBER - July 23, 2009 Category: Biomedical Science Source Type: organizations